A Study to Learn How Different Injector Pens Affect the Study Medicine Called Genotropin (Somatropin) Delivery and Taken up Into the Blood in Healthy Adults
NCT07542886 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2026-05-11
Summary
The purpose of this clinical study is to learn about how different injector pens affect:
* how the study medicine (called Genotropin) is delivered into the body and
* how the study medicine is taken up into the blood in healthy adults.
The study is seeking participants who are:
* Aged 18 to 60 years old
* Male or female who are healthy as determined by medical assessment
* Body-mass index (BMI) of 16 to 32, and a total body weight more than 45 kg. BMI is a way to estimate a healthy body weight for an adult's height.
Adults in this study will receive study medicine by a shot under the skin. The study medicine will be given using 2 different injector pens which are medical devices that give a shot under the skin. Blood samples will be taken before and after the shots to look for the study medicine. We will compare the amount of study medicine in the blood between shots from the 2 injector pens.
Adults will take part in this study for about 10 weeks including the screening period. They will have to stay at the study clinic for at least 13 days. This includes 2 study periods in total. A follow up phone call will be made 23 to 30 days following the last study period.
Conditions
- Healthy
Interventions
- DEVICE
-
Marketed Genotropin Pen 12
Growth Hormone Delivery Device for use with Somatropin for injection
- DEVICE
-
New Genotropin Injector Pen
Growth Hormone Delivery Device for use with Somatropin for injection
- DRUG
-
Genotropin 4mg
4mg subcutaneous
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-04-22
- Primary Completion
- 2026-06-25
- Completion
- 2026-07-22
- FDA Drug
- Yes
Countries
- Belgium
Study Locations
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